Review of the adequacy of current regulatory regimes to ... · Health and Safety Executive Review of the adequacy of current regulatory regimes to secure effective regulation of nanoparticles

Health and Safety Executive

Review of the adequacy of current regulatoryregimes to secure effective regulation ofnanoparticles created by nanotechnologyThe regulations covered by HSE

Contents1 The reason for the review 22 Background information 23 Is a nanomaterial ‘new’ and hence notifiable under NONS? 44 NONS Regulations: Issues for a notifiable material 55 Chemicals (Hazard Information and Packaging for Supply) Regulations (CHIP)

76 Workplace risk management 87 Other specific legislation (EU Existing Substances Regulations; Biocidal

Products Regulations; Major Hazard (COMAH) legislation) 128 REACH 139 Conclusions 14

Appendices:I Conclusions of the Royal Society and Royal Academy of Engineering report

‘Nanoscience and nanotechnologies: opportunities and uncertainties’ 15II Summary from HSE (2004) review: ‘A review of the toxicity of particles that are

intentionally produced for use in nanotechnology applications, seen from anoccupational health perspective’ 17

III Summary from HSE (HSL report 2004): ‘Literature review – explosion hazardsassociated with nanopowders’ 18

IV Summary from HSE-sponsored research (2004): ‘Nanoparticles: Anoccupational hygiene review’ 19

References 22Further information 22

1 The reason for the review1 Recommendations 8 and 11 of the Royal Society and Royal Academy ofEngineering report ‘Nanoscience and nanotechnologies: opportunities anduncertainties’ (see Appendix I) make reference to the need for government toconsider the adequacy of regulatory frameworks in relation to nanoparticles,especially nanoparticles that will arise from the application of nanotechnology. Thegovernment accepted these recommendations. Accordingly, each governmentdepartment has undertaken to analyse and document how current regulations forwhich they have responsibility accommodate nanoparticles. This is HSE’s analysisin relation to its responsibilities. The aim of this review is therefore to set out anddiscuss issues arising in relation to the following:

■ whether or not nanoparticles are covered by the scope of the regulations forwhich HSE has responsibility; and

■ whether or not the requirements of these regulations are appropriate andsufficient to protect human health in relation to occupational exposure tonanoparticles (this does not include the availability of advice relevant tonanoparticles).

2 Background information 2 With respect to nanomaterials, HSE has critically reviewed the availableinformation on their physicochemical and toxicological hazards of relevance in theworkplace and the occupational exposure situation (see summaries attached asAppendices II, III and IV). The reviews focused on poorly soluble or insolubleparticles (including fibres) intentionally generated to have applications innanotechnology, with one or more physical dimension(s) being less than 100 nm(0.1 micrometre). These reports indicate that there are very few good qualitystudies on novel nanomaterials of relevance to the assessment of human healthhazards or exposure, although some limited but useful information is also availableon more familiar materials reduced in size to the nanoscale.

3 Given the paucity of information available and the concerns raised by some ofthe data that does exist, a cautious approach to risk management has beenrecommended in an information note aimed at researchers and developerspotentially exposed to nanomaterials (HSE, 2004).

Overview of current legal framework

4 Legislation to regulate the health and safety hazards of industrial chemicals andthe risks they pose in the workplace has been developed and standardised acrossthe European Union (EU); these regulations have been accommodated in the UKunder the umbrella of the Health and Safety at Work Act 1974 (the HSW Act).There are also other agreements determined at a global level that may influencethese EU regulations, for instance the Globally Harmonised Scheme forclassification and labelling and the OECD guidelines for the testing of chemicals. Inreviewing the current legislation the reader should be aware that the EU chemicalspolicy is on the verge of a major shift to a different regulatory framework based onthe ‘Registration, Evaluation and Authorisation of Chemicals’ (REACH) which willhave consequences for all the current legislation addressed in this review. Hence,at this time, there is little opportunity to modify the current legislation. It is alsopremature to specify precisely how future REACH-related legislation wouldaccommodate the relevant issues identified in this review, as the negotiationsshaping the new legislation are ongoing.

2 of 22 pagesReview of the adequacy of current regulatory regimes to secure effective regulation ofnanoparticles created by nanotechnology




5 The current regulatory framework and the roles involved can be summarised asfollows.

Legislation aimed at suppliers

6 EU Directives implemented in the UK by the Chemicals (Hazard Information andPackaging for Supply) Regulations (CHIP) require that suppliers of chemicals shouldseek out and convey information to the recipients on the physicochemical (egflammability) and toxicological hazards of their chemicals. This is done through EU-standardised classification and labelling (C&L) and Safety Data Sheets (SDS). Inrecognition of the dearth of reliable hazard information on many industrial chemicals,the 7th Amendment to the EU Dangerous Substances Directive (DSD) implementedin the UK as the Notification of New Substances (NONS) Regulations, requires(among other things) standardised testing of hazardous properties of industrialchemicals new to the market. There is also a responsibility on suppliers to addressthe downstream risks and their management. Since the early 1990s there has alsobeen an EU-wide attempt to capture and improve the hazard information availablefor older industrial chemicals, and to assess the risks to health and safety via theExisting Substances Regulation (ESR). However, activity under this regulation is nowwinding down, in anticipation of the future REACH regime, which will subsume thesesupply-side regulations and extend the principles of supplier responsibility further.

7 The supply of biocides is addressed by EU Directive 98/8/EC which establishesa regulated single European market in biocides based on risk evaluation andharmonised authorisation. In 2001 this Directive was implemented as the BiocidalProducts Regulations (BPR) in Great Britain and its equivalent regulation in NorthernIreland. Over time, these Regulations will replace the current UK national approvalscheme for non-agricultural pesticides under the Control of Pesticides Regulations(1986 as amended) that remain in force until substances have been assessed underthe new regulations. Under BPR and its equivalent regulations elsewhere in the EU,industry will be required to submit data on the active substance and a representativeformulation which addresses the hazardous properties, classification and labellingand necessary risk management procedures, which will be evaluated by MemberStates (MS) and a risk assessment conducted. Evaluations are then harmonised andmade usable across the EU under the principle of mutual acceptance of data.

8 Recipients/users of chemicals (and manufacturers/suppliers in relation to theirown sites) are responsible for understanding their local situation. Using theinformation from suppliers, they should assess and appropriately manage the extentof worker exposure to hazardous chemicals so as to eliminate, or at least minimise,the health and safety risks ‘so far as is reasonably practicable’. This is a requirementof the EU Chemical Agents Directive and the Carcinogens Directive transposed intothe UK legislation in the Control of Substances Hazardous to Health Regulations(COSHH) and Dangerous Substances and Explosive Atmospheres Regulations(DSEAR).

9 As a regulatory authority, HSE, with others, is responsible for the negotiation,agreement and enforcement of these regulations. In addition to contributing to thedevelopment of the regulatory framework, HSE also plays a more detailed role forsome individual substances, for example by agreeing and specifying theirclassification or by establishing the appropriate degree of control of airborneexposure in the workplace via Workplace Exposure Limits (WELs). HSE also plays arole in the enforcement of the regulations concerning the storage of some hazardousmaterials under the Control of Major Accident Hazards Regulations (COMAH, 2005as amended). This deals with assessing the risks and consequences to thesurrounding populace and environment of fire, explosion and substantial release oftoxic chemicals in an industrial accident situation.



10 In addition to the regulations there are different types of documented advice:eg ‘Approved Codes of Practice’ (ACOPs) and ‘Approved Guidance’ help dutyholders to understand their duties and to carry them out to a legal standard. Ifchallenged, the duty holder must be able to justify any deviations from theguidance given in these documents. Additional guidance to the regulations is alsoavailable, which also allows specific advice to be changed more quickly than wouldbe the case with a regulation or ACOP.

11 Fundamental to the effective operation of this regulatory framework is theavailability of reliable information on the properties of the substance in question.Historically, many substances have been marketed and used without theirhazardous properties having been fully explored. The advent of the NONSRegulations required suppliers to produce a standardised set of information on theproperties of their ‘new’ substance before introducing it onto the market. Hence, akey question for any nanomaterial is whether or not it is considered a newsubstance that requires notification under NONS.

3 Is a nanomaterial ‘new’ and hencenotifiable under NONS? 12 The concept of a ‘new’ substance was defined in the late 1970s. To assist inthe EU-wide operation of what in the UK are the NONS Regulations, a list ofsubstances that were already supplied in the EU was drawn up. These wereentered into a database called the European INventory of Existing CommercialChemical Substances (EINECS). Standardised naming conventions and specificcriteria were used to draw up the list. The substances on the inventory were called‘existing’; after this, any substance intended for placing on the market for the firsttime is designated ‘new’ and subject to notification requirements (with theexception of ‘special category’ substances covered by other specific legislation egfoods and food additives, pesticides, pharmaceuticals etc).

13 It is the responsibility of the supplier to determine whether or not theirsubstance is on EINECS and therefore ‘exisiting’. In some cases, the identity of thesubstance to be supplied can be difficult to describe or an EINECS entry can bedifficult to interpret. When this occurs, the opinion of the ‘competent authority’ (CA)in the relevant Member State can be sought. HSE in partnership with theEnvironment Agency (EA) is the relevant UK CA for NONS. Over the years thatNONS has been in force, many such questions have been raised both in the UKand in other EU MS. The outcomes and decisions made have been recorded into a‘Manual of Decisions’. This document records precedents and procedures for theinterpretation on the New Substances legislation; it is helpful guidance but notlegally binding.

14 As yet there are no entries in the Manual of Decisions relating to the issue ofnanoparticle notification. HSE’s current thinking on whether or not individualnanomaterials can be being regarded as ‘new’ is explained in this review.

15 In relation to their production, nanomaterials roughly divide into two classes:‘top-down’ and ‘bottom-up’. ‘Top-down’ nanomaterials are those made by makingfamiliar substances at the nanoscale (eg by grinding down). Broadly speaking, suchmaterials are less likely to require notification under NONS. There is more potentialfor novel substances made as nanomaterials by ‘bottom-up’ construction torequire notification. There are two examples already in the regulatory domain,illustrated in the following examples.



16 In relation to suppliers making an initial judgement as to whether or not theirsubstance may be new, general information is freely available (publications, HSEInfoline, HSE website, European Chemicals Bureau website) to assist suppliers tojudge whether or not the relevant criteria are met. However, in our view, more willneed to be done to raise the awareness of those involved in the manufacture andsupply of nanomaterials about the potential notifiability of novel nanomaterials and todevelop appropriate guidance.

4 NONS Regulations: Issues for a notifiablematerial 17 If a nanomaterial is deemed to be notifiable under NONS, a structured notificationprocedure applies. A NONS package requires information in the following categories,under which the particular issues arising from nanomaterials are discussed.

NONS: Identity and properties

18 The critical issues here relate to particle size and shape. For engineerednanomaterials there is a need to know the physical characteristics and dimensions ofthe particles. The commonly used granulometric tests used to determine particle sizeranges may not be appropriate for nanoparticles; in many cases electron microscopywill be needed to ascertain particle dimensions. While use of electron microscopy isan option in the current EC guidance on granulometry to assess the physicalcharacteristics of particles, the necessity to use this method for notifiednanomaterials will need to be stressed to notifiers.

NONS: Hazard identification

19 Data from standard test methods, or information equivalent to this standard, isrequired on the physicochemical, toxicological and eco-toxicological properties ofnotified substances. The studies should be performed to agreed quality standards(methods equivalent to those in Annex V of DSD, OECD Test Guidelines). In HSE’sopinion, the available test guidelines for the assessment of physicochemical andhuman health hazards will be able to capture the necessary information on thehazardous properties of nanomaterials.

Example 1 – A ‘top-down’ materialTitanium dioxide in a nanoscale form demonstrates desirable properties for usein sunscreens. There is an entry for ‘titanium dioxide’ in EINECS and theparticle size of a solid substance does not affect its EINECS status. Therefore,we would consider that the nanomaterial is not subject to notification underNONS.

Example 2 – a ‘bottom-up’ nanomaterial where NONS may applyVarious carbon structures in the form of fullerenes were some of the firstbottom-up nanomaterials. Carbon has three entries in EINECS, two for theallotropes graphite and diamond and one for amorphous carbon. Carbonfullerenes are regarded by a an authoritative body of experts, the InternationalUnion of Physical and Applied Chemists (IUPAC), as distinct and separateallotropes of carbon. Hence, we consider that the entries for carbon onEINECS do not cover the fullerene allotropes (or their derivatives). Thus, carbonfullerenes and their derivatives, including carbon nanotubes, should beregarded as ‘new’ chemicals.

20 Regarding testing strategies, HSE’s current thinking is that the timing andextent of testing required may need to be different from a standard NONSpackage. For example, it could be useful to have data at an early stage on theability of the nanomaterials to be absorbed across the respiratory tract, skin andgastrointestinal tract. Early data on its likely distribution around the body onceabsorbed would also be useful, so as to obtain information on which are the mostappropriate toxicological endpoints on which to focus attention. For all newsubstances, guidance indicates that toxicological testing should be conductedusing the most relevant route of exposure. However, in general, many notifiedsubstances are tested for acute and repeated-exposure toxicity via the oral route.For nanomaterials in the form of nanoparticles, it appears to us that the inhalationroute should be brought into play earlier and more often because of the identifiedconcerns for toxicity towards the respiratory tract via this route of exposure.

21 Nowadays within NONS there is considerable use of ‘read-across’ (see section5 for details). This approach has the potential to greatly reduce the burden oftesting, particularly toxicological testing using experimental animals. There could becontentious or difficult issues in seeking to use read-across approaches fornotifiable nanomaterials.

NONS: Exposure assessment

22 There is also a need to assess the potential for exposure. Given that thenotification process will pre-empt full-scale production there is not usually anymeasured data available. Therefore, exposure assessment tends to be morequalitative, with a reliance on semi-quantitative modelling to predict potentialexposure using the EASE (Estimation and Assessment of Substance Exposure)model. The ability of this model to accommodate nanomaterials will need to beexamined and further developed as more information becomes available on theproperties of nanomaterials. For example, at present the exposure predictions thatthe EASE model gives are based on mass of either inhalable or respirable particles;a different metric might be needed for nanoparticles.

NONS: Risk assessment and risk management

23 There is also a need for the notifier to conduct a risk assessment, with the helpof the CA if necessary. To assist in the judgment about the completeness of a riskassessment, the CA has some flexibility under NONS to request further informationif ‘it is satisfied that the further information is reasonably required to evaluate therisks created by the substance to human health or the environment’. Hence, theinformation requirements of the current regulations appear to be sufficiently flexibleto accommodate the pursuit of any issues of concern.

24 The information generated for a NONS notification should enable recipients ofnew substances who use them in their workplace to apply satisfactorily therequirements of COSHH. In terms of controlling the potential for exposure tonanomaterials, the main tools likely to be recommended for nanomaterials arecontainment and the use of personal protective equipment (PPE). These issues arediscussed further in the section on COSHH.

25 Many of the same issues discussed above will translate across to other ‘supplyside’ regulatory schemes based on health assessment, exposure assessment andrisk management (eg BPR, ESR ).





5 Chemicals (Hazard Information andPackaging for Supply) Regulations (CHIP)

26 CHIP enacts the EC Dangerous Substances Directive (DSD), the DangerousPreparations Directive, and the Safety Data Sheet Directive. The CHIP Regulationsmake it the responsibility of suppliers to:

■ identify, and where appropriate, categorise the hazards of the material assupplied using internationally agreed criteria - this is called classification;

■ give information about the hazards and appropriate precautions to the user,normally through labelling on the product packaging and a suitable Safety DataSheet; and

■ package the material safely.

27 CHIP applies to the vast majority of supplied ‘substances’ and ‘preparations’(mixtures of substances), if hazardous. Some chemicals such as cosmetics andmedicines are outside the scope of CHIP and have their own legislation; theassociated work is led by government departments other than HSE.

28 The issue of ‘objects’, sometimes called ‘articles’, also impinges on CHIPlegislation. CHIP does not define articles, but in using this term refers to a definitionpreviously used to determine if a substance was reportable under EINECS (an‘object’ was excluded from reporting). Under CHIP, objects which by their userelease hazardous substances, creating potential exposure for the user, may needto be packaged and labelled to indicate the presence of classified substances. Thefuture of nanotechnology holds the potential for the creation of ‘nanodevices’,entities that are nanomaterials or contain nanomaterials within them. As regards thenanomaterials in such a ‘device’, the implications and requirements in relation toCHIP will need to be worked through.

29 Once a nanomaterial entity is considered within scope of CHIP then there arethree issues, covered under the subheadings below.

Classification and labelling of an individual substance

30 Nanomaterials examined under NONS, ESR or BPR in the UK (or, in other EUMember States, the corresponding regulations) will have their classification andlabelling agreed at EU level and entered into ‘Annex I’ of the DangerousSubstances Directive.

31 This ‘Annex I’ (transposed into the UK ‘Approved Supply list’, ASL) also liststhe C&L for a considerable number of other existing substances that have beenthrough the EU-wide procedure of agreeing C&L positions. Suppliers are obliged touse this classification if the substance is listed.

32 As yet, no ‘existing’ substances in nanosized form have been through this EUsystem. In such a situation, the supplier of such a material will need to gather andconsider all of the relevant data on that substance and determine the classificationthemselves using the guidance available (principally, Annex VI to the DSD, or in theUK, the Approved Classification and Labelling guide). This process is called ‘self-classification’; in undertaking it there could be two problems, as seen from theregulatory authority standpoint.

33 Absence of data on the nanomaterial in question. From the review summarisedat Appendix (II) it is apparent that currently there is a distinct lack of data available

on the hazards of existing substances in their nanoform. In our experience, somesuppliers of chemicals regard the absence of data as being synonymous with theabsence of hazard. It is a concern that such a philosophy could lead to a supplierof a nanomaterial not assigning classification or labelling to their substance, withoutany attempt being made to think through its potential health hazards.

34 Inappropriate use of ‘read-across’. Some suppliers of existing substances lookfor data on structurally related chemicals and read across such data as aprediction of the toxicity of the substance being supplied. Regulatory authoritiesalso use this approach; for example in the EU, unless there is data to showotherwise, all isocyanates should be classified as sensitising and labelled ‘Maycause sensitisation by inhalation’. However, read-across must be used judiciously.We are concerned that suppliers of a nanosized material may consider readingacross directly data available for the microsized form. However, it is evident that theproperties of nanoscale entities are not necessarily the same as the microsizedform of the same substance.

35 Concerns surrounding these issues illustrate the need for appropriate guidance.

Classification and labelling of a preparation

36 The classification and labelling of a preparation can be determined from dataon the preparation itself and/or by calculation methods using the data and knownclassification of the components. There might be issues here in relation tonanomaterials but at this stage they are too speculative and detailed to be includedin this document.

Safety Data Sheet requirements

37 The requirements of CHIP to make available Safety Data Sheets with specifiedformat for the laying out of information will apply to hazardous nanomaterials. Incompleting a SDS, the heading structure will bring out a number of issues coveredelsewhere in this review. The important role played by SDSs raises concerns for thequality of the information that will be included by suppliers and the interpretation ofthat information by users. We have already seen, in an SDS for carbon nanotubes,references made to hazard information on respirable graphite, without any furtherexplanation to users about the relevance of such data.

6 Workplace risk managementControl of Substances Hazardous to Health (COSHH)Regulations

38 The COSHH Regulations require employers to either prevent, or where this isnot possible, control the potential risks from exposure to hazardous chemicals fortheir particular work situation. The principles of COSHH follow a familiar pattern inthat there is a need to assess the hazards, the potential for exposure and the risksposed to worker health; from there, employers then need to make riskmanagement decisions and to specify the hierarchy of the measures that will beapplied to deliver adequate control. COSHH has recently been amended (in 2004)to emphasise the principles of good practice for control of exposure by placingwithin the regulation itself the requirement to apply the ‘eight principles of goodpractice’.





39 In COSHH a substance is deemed to be ‘hazardous to health’ if it meets oneor more of the following criteria:

■ is listed in the Approved Supply List with a classification of Harmful, Toxic, VeryToxic, Irritant or Corrosive;

■ is present as a dust at a concentration greater than 4 mg/m3 (respirablefraction) or 10mg/m3 (inhalable fraction), as 8-hour time-weighted averagevalues;

■ has an approved occupational exposure limit; and/or■ represents a risk to human health from its presence or the way it is used in the

workplace.

‘Hazardous’ materials in the scope of COSHH include both supplied substancesand substances generated during work activity.

COSHH: Assessment of hazards and exposure

40 COSHH regulation 6 specifies that an employer has to assess the risks arisingfrom work by using available information on the hazards and knowledge of the localconditions of exposure. Regulation 6 sets out the elements which are required in aCOSHH risk assessment. The ones of most relevance to this review are:

■ hazard; ■ exposure; ■ the circumstances of the work; ■ the results of any exposure monitoring; and ■ the results of any health surveillance.

41 Therefore, in order to do a suitable and sufficient assessment, a substantialamount of information is required. For nanomaterials, our current perspective is thatthere are deficiences in the available information available, ie we lack:

■ sufficient toxicological hazard information for most nanoparticles; ■ reliable, affordable and standardised exposure measurement and

characterisation methods; and■ an agreed definition of the most appropriate dose metric(s) to use in hazard

and exposure studies.

42 Without these basic strands of information, carrying out a reliable COSHH riskassessment will be very difficult. Also, without sufficient hazard information it isdifficult to know when and in what form health surveillance becomes appropriate.

43 The purpose of the assessment is for employers to be able to demonstrate tothemselves and others (including safety representatives and enforcing authorities)that they have made valid decisions about the measures necessary to prevent oradequately control the exposure of employees to hazardous substances arisingfrom their work. They need to show that they have considered all of the factorspertinent to the work and reached an informed and valid judgement on the risksand the management of them. With the current level of information and knowledgeon nanomaterials this will be very difficult.

44 Often employers rely on the information given in a supplier’s Safety Data Sheetto carry out their assessment. However, the completion of an SDS for ananomaterial is beset by the same problems.

45 Until such time as there is sufficient information and knowledge available on thetoxicological hazards, the appropriate dose/exposure metric(s) and the levels ofexposure to nanoparticles experienced, employers will not be able to carry out



adequate risk assessments. However, once the relevant information becomesavailable, there should be no reason why employers cannot fulfil their duties underCOSHH.

46 One issue which may require attention in relation to the treatment ofnanomaterials under COSHH is the definition of dust exposures deemed to bepotentially hazardous to health. From current, limited understanding of thetoxicology of nanomaterials it would be unwise to regard exposures tonanomaterials at or below 4 mg/m3 (8h TWA) respirable dust as representingadequate control associated, confidently, with health protection.

COSHH: Prevention or control of exposure

47 COSHH Regulation 7 requires employers to ensure that the exposure ofemployees to hazardous substances is either prevented, or where this is notreasonably practicable, adequately controlled. It gives a list of control measuresappropriate to the activity, in order of priority, that can be used. There are extraprovisions for control of carcinogens and mutagens in addition to the ones givenfor other substances.

48 Regulation 7, as amended in 2004, now also states that control of exposureshall only be treated as adequate if:

■ the principles of good practice for the control of exposure are applied; ■ any Workplace Exposure Limit (WEL) is not exceeded; and ■ exposure to any carcinogen, mutagen and asthmagen is reduced to as low a

level as is reasonably practicable.

Prevention of exposure49 An employer’s first duty is to prevent exposure, other than by means of PPE.The best way to comply with this requirement is to eliminate the substance entirely.Given the current high cost of nanomaterials, it is likely that they will only be used inapplications for which they have a specific and integral purpose and thereforesubstitution is not likely to play a major role in prevention of exposure.

Control of exposure50 Where prevention of exposure is not reasonably practicable, employers mustcomply with the duty to adequately control exposure by all routes. To achieve thisthey must consider and apply, where appropriate:

■ the design and use of appropriate processes, systems and engineeringcontrols;

■ the provision and use of suitable work equipment and materials;■ the control of exposure at source; ■ where adequate control of exposure cannot be achieved by other means, the

provision of suitable PPE;■ the principles of good practice for the control of exposure of hazardous

substances; and ■ the requirement not to exceed any Workplace Exposure Limit (WEL).

There are additional requirements for carcinogens and mutagens.

51 An employer must apply the principles of good practice in all circumstances,but it will not always be necessary to use all of the available control options. Theprinciples of good control elucidated in COSHH give general advice and as suchwill be adaptable to cater for the control of exposure to nanomaterials. However,there will be issues to examine surrounding the performance and effectiveness ofconventional control approaches, including PPE, when applied to nanomaterials.



52 One of the recommendations in the Royal Society/Royal Academy ofEngineering report (Appendix I) is to suggest the introduction of occupationalexposure limits for manufactured nanoparticles that are lower than might be thecase for somewhat similar materials in larger particle form. The current (newlyintroduced) single type of occupational exposure limit in the UK is the WorkplaceExposure Limit (WEL). At present, WELs are based on the mass of inhaled particlesand all have been derived from information on, and with the thinking that theywould be relevant to, larger sized particles. If a current WEL for any individualsubstance were to be applied to the same material in a nanosized form we wouldnot be confident of health protection when inhaling the vast numbers ofnanoparticles inherent in such an exposure. However, at present we do not havesufficient data to know whether or not to adjust downwards any such WEL value tocater specifically for the substance in nanosized form and, if so, by what amount.Furthermore, the listing of two (or more) different WEL values alongside the samesubstance name, covering different size fractions, might be confusing.

53 The other option is to build up from first principles the derivation of a specificWEL for each nanomaterial of interest. As yet, we do not have sufficient knowledgeon the toxicological hazards, appropriate dose/exposure metric(s) andprevailing/potential exposure conditions to do this. This is an issue which will needto be revisited when there is more of such data available on nanomaterials.

COSHH: Monitoring exposure

54 When a COSHH assessment indicates the need, monitoring of exposureshould be carried out using a valid and suitable method. Although some methodsto measure nanoparticles are available currently, they are not practical for routinemonitoring of personal exposure in the workplace, requiring the use of large piecesof expensive equipment that are not easily portable. Research is underway to try todevelop a portable personal sampler. A decision will also need to be made on themost appropriate exposure metric(s) to use in making exposure assessments.

55 Nanoparticles in the form of fibres, such as carbon nanotubes, may needspecific exposure measurement methods to be developed. Current methods offibre counting involving light microscopy would not be appropriate with nanoscalefibres.

COSHH: Health surveillance

56 COSHH regulation 11 requires health surveillance to be carried out where it isnecessary for the protection of employees’ health. The stated objectives of suchhealth surveillance are: to protect the health of individual employees by detectingas early as possible adverse changes that may have been caused by exposure tohazardous substances; to help evaluate the effectiveness of measures taken tocontrol exposure; and to collect and use data for determining and evaluating thehazardous properties of substances.

57 Currently there is insufficient knowledge of the risks to health posed bynanomaterials under specified circumstances to enable employers or regulators tomake valid assessments of what health surveillance would be appropriate andwhen.

COSHH: Instruction and training

58 Employers must provide employees with suitable information, instruction andtraining to allow them to carry out their jobs in a safe manner. This includesinformation on the risks to health and what the employee needs to do to controltheir exposure. Despite the evident gaps in knowledge for nanomaterials,

employers should still inform their employees about what is known and what theemployer considers to be the appropriate guidelines to be followed for safeconditions of work.

COSHH: Risks to others

59 COSHH requires employers to address the risks not only to workers but also toother people on the premises or others who might be directly affected by the workactivity, ‘so far as is reasonably practicable’. Employers and other stakeholders willneed to equip themselves to assess the risks posed by a nanomaterial to suchpeople.

Summary of issues under COSHH

60 Overall, the principles and basic elements of COSHH are appropriate toaccommodate the challenges provided by nanomaterials in the workplace.However, for many actual or potential future nanomaterials there is a lack of thenecessary relevant information in a number of important areas to allow employersto conduct the necessary assessments, and for employers and regulators to judgewhether or not those assessments are adequate.

61 As more information becomes available, ACOPs and other guidance in supportof COSHH may need to be revised to take account of both the uncertainties andwhat become the known differences between nanomaterials and other substances.

Dangerous Substances and Explosive AtmospheresRegulations (DSEAR)

62 Substances capable of forming explosive atmospheres fall under DSEAR andthe requirements of these Regulations to assess and manage the risk of explosion.There is a need to identify those materials which may be explosive and, explosivitybeing an issue for dusts in general, this is a consideration for nanoparticles whichmay become airborne. A recent review of fire and explosion hazards reported thatit is not possible to predict these properties for nanomaterials on the basis of theknowledge gained from testing larger sized particles (Pritchard (2004)). Given theuncertainties regarding the properties of nanomaterials in this respect, until betterdata is available there is a need for users to understand that there are uncertaintiesregarding flammability and explosivity surrounding the use of nanomaterials.

7 Other specific legislation (EU ExistingSubstances Regulation; Biocidal ProductsRegulations; Major Hazard (COMAH)legislation)

Existing Substances Regulation (ESR)63 The EU Existing Substances Regulation (and, for the UK, the associated UKenforcement regulations) require suppliers of existing chemicals to submit hazardinformation to the European Commission. This is a prelude to the prioritisation,selection and undertaking of comprehensive risk assessments leading toconclusions about the need for risk management measures beyond those currentlyin place, to protect all sectors of the human population and the environment. TheUK Competent Authorities for ESR are HSE and the Environment Agency (EA).



None of the substances reviewed to date have been identified as being available inthe form of nanoparticles. In anticipation of the forthcoming REACH regulations(see section 8), very few if any further substances will be assessed under ESR.Hence there is nothing further to consider here in the context of nanomaterials.

Biocidal Products Regulations (BPR)

64 HSE is the UK Competent Authority for the regulation of biocidal productsacross the EU under Biocidal Products Directive 1998, enacted in the UK as theBiocidal Products Regulations (2002, and amendments). No nanoscale substanceshave yet been identified as coming under the requirements of these Regulations.However, there is the potential for this to change in the future. Were this to be thecase, the issues that would arise are similar to those covered above in relation toother legislation.

Control of Major Accident Hazards Regulations (COMAH)

65 COMAH legislation requires notification (in the UK, to HSE) of sites wheresubstances with hazardous properties that correspond to certain CHIPclassification criteria are stored in quantities above specified tonnage triggers. Partof the notification procedure is to reach agreement between the site operator andthe regulator on a risk assessment and the identification of the necessary measuresto mitigate the risks of a release to as low as is reasonably practicable. The onus ison the site operator to identify the appropriate hazard classification of thematerial(s) stored, in order to determine whether or not COMAH applies. This raisesissues discussed previously in this review concerning the identification of thehazards of nanomaterials. However, at this stage in the development of thenanotechnology industries, it seems unlikely that the quantities of materials beingproduced and stored will be relevant to this legislation.

8 REACH66 It is anticipated that new legislation on chemicals, known by the acronymREACH (Registration, Evaluation and Authorisation of Chemicals) and currentlyunder negotiation, will be introduced across the EU sometime in the next few years(possibly 2007). It is expected that some current major pieces of chemicalslegislation, including NONS and ESR, will be replaced by the REACH system.

67 Given that the content and procedural aspects of REACH are currently underactive negotiation, it is premature to assess in detail in this review how REACH willaccommodate nanomaterials. However, one key feature of the draft REACHsystem is that the tonnage triggers for required information are higher than inNONS. Given that it seems likely that many nanomaterials will be specialitychemicals produced at relatively low tonnages, it might well be that the demand forthe collection and submission into the regulatory system of information onnanomaterials may be more relaxed under REACH than it would be for ananomaterial deemed subject to the requirements of the current NONSRegulations. Those negotiating the final form of the REACH legislation may need togive this point some consideration.68 Beyond this, the issues raised above in relation to current legislation will needto be borne in mind and carried through appropriately into the REACH system, inrelation to both novel nanomaterials created by a ‘bottom-up’ process and the‘top-down’ conversion of familiar substances into nanosized forms.





9 Conclusions69 This review has considered the relevant regulations for which HSE is (fully or inpartnership with others) the responsible authority in the UK and has examined howsuch legislation accommodates nanomaterials. The regulations covered areconcerned with the protection of health and safety in the workplace and, in somecases, with the assessment of hazards and risks to health of humans in all sectorsof the population. The review has attempted to consider both the current positionand also likely developments in the future, in terms of the nanotechnology industry,the advancement of scientific research and understanding of the properties ofnanoparticles, and foreseeable changes in the regulatory framework.

70 The overall conclusion reached is that the principles of the existing regulationsand the interconnections between them are appropriate and applicable tonanomaterials. We perceive no need to fundamentally change the regulationsthemselves, nor to introduce new regulations. However, there are important issueswhich require attention if, in reality, the current and foreseeable future generalregulatory framework is to operate effectively in relation to nanomaterials.

71 In this context, four themes are drawn out here that need to be borne in mindand responded to appropriately.

72 Firstly, there are currently many gaps in our knowledge of nanoparticles suchthat there are important uncertainties surrounding the toxicological andphysicochemical hazards, the appropiate dose/exposure metric(s), the means ofmeasuring exposures, the risks to health and the effectiveness of control measures.This absence of data and knowledge means that all involved in the regulatoryprocess (eg manufacturers and suppliers, recipients and users, regulatoryauthorities) will have great difficulty at present in confidently discharging theirresponsibilities within the various regulations covered here. However, we do expectthat there will be rapid advances in understanding of the scientific andtechnological issues surrounding nanomaterials, such that one can havereasonable confidence that this position will be much improved in the next fewyears.

73 Secondly, there are currently several areas where, because of the newness ofthe nanoparticles field and the gaps in understanding, judgements need to beexercised to determine the appropriate position within various regulations andregulatory obligations. There is clearly the potential for different players within theregulatory systems to reach different judgements on such matters. Three examplesare:

■ the notifiability of, and associated information gathering and submissionrequirements for, a novel nanomaterial under the NONS Regulations (seesection 3);

■ ‘reading across’ toxicological hazard data from materials of larger particle sizeto nanomaterials judged to be somewhat related in chemical or physical terms(see section 5);

■ in the absence of data, the appropriate conclusions to draw and actions totake in relation to workplace risk assessment and risk management ofnanomaterials.

HSE has already issued an Information Note (HSE 2004a)1 in relation to the lastpoint, but we suggest that there is more to be done to bring all participants in thevarious regulatory processes to the same level of understanding and judgement.

74 Thirdly, it must be recognised that all of the legislation reviewed here is notspecific to the UK but operates on an EU-wide basis. Furthermore, not only are the

regulations EU-wide, but also (and increasingly) the accompanying guidance,precedents (captured in manuals of decisions) and standards (eg specificclassification decisions, occupational exposure limits) are also reflections of EU-wide agreements. There is almost no scope for changing regulations andsupporting elements on a purely national, UK basis; almost all such envisagedchanges would need to be negotiated and a position ultimately agreed across theEU. In some cases (eg test methods) the international dimension goes wider thanthe EU, for example to the OECD.

75 Fourthly, much of the current EU legislation discussed in this review will bealtered, in some cases dramatically and even to the point of being subsumed, bythe envisaged REACH system that is currently under negotiation. Alongside this, itis also now envisaged that the new Globally Harmonised Scheme (GHS) forclassification and labelling of substances and preparations will be introduced intothe EU in the next few years, replacing the current EU C&L system. Realistically,one can anticipate that across the EU there will be little appetite for negotiating indepth and/or bringing about significant changes to current legislation which mighttake a considerable time to resolve, only to be swept away within a short timeperiod by the introduction of REACH (and GHS). Indeed, it might be moreprofitable to concentrate such regulatory negotiation efforts on issues surroundingthe envisaged treatment of nanomaterials within REACH (and GHS), rather than, forexample, within current NONS and C&L/CHIP legislation.

Appendix IAbstracted from the Recommendations of ‘Nanoscience and nanotechnologies:opportunities and uncertainties’ July 2004.2

Regulatory issuesR8 We recommend that all relevant regulatory bodies consider whether existingregulations are appropriate to protect humans and the environment from thehazards outlined in this report and publish their review and details of how they willaddress any regulatory gaps.

R9 We recommend that regulatory bodies and their respective advisory committeesinclude future applications of nanotechnologies in their horizon scanningprogrammes to ensure any regulatory gaps are identified at an appropriate stage.

Recommendations R10 to R14 are based on applying our conclusions - that somechemicals are more toxic when in the form of nanoparticles or nanotubes and thatsafety assessments based on the testing of a larger form of a chemical cannot beused to infer the safety of chemicals in the form of nanoparticles - to a series ofregulatory case studies.

R10 We recommend that chemicals in the form of nanoparticles or nanotubes betreated as new substances under the existing Notification of New Substances(NONS) Regulations and in the Registration, Evaluation, Authorisation andRestriction of Chemicals (REACH) (which is currently under negotiation at EU leveland will eventually supersede NONS). As more information regarding the toxicity of



nanoparticles and nanotubes becomes available, we recommend that the relevantregulatory bodies consider whether the annual production thresholds that triggertesting and the testing methodologies relating to substances in these forms shouldbe revised under NONS and REACH.

R11 (i) We recommend that the Health and Safety Executive (HSE) review theadequacy of its regulation of exposure to nanoparticles, and in particular considersthe relative advantages of measurement on the basis of mass and number. In themeantime, we recommend that it considers setting lower occupational exposurelevels for manufactured nanoparticles.

(ii) We recommend that the HSE, Department for Environment Food and RuralAffairs and the Environment Agency review their current procedures relating to themanagement of accidental releases both within and outside the workplace.

(iii) We recommend that the HSE consider whether current methods are adequateto assess and control the exposures of individuals in laboratories and workplaceswhere nanotubes and other nanofibres may become airborne and whetherregulation based on electron microscopy rather than phase-contrast opticalmicroscopy is necessary.

R12(i) We recommend that ingredients in the form of nanoparticles undergo a fullsafety assessment by the relevant scientific advisory body before they arepermitted for use in products. Specifically: we recommend that industry submit theadditional information on microfine zinc oxide that is required by the SCCNFP assoon as reasonably practicable so that it can deliver an opinion on its safety.

(ii) We recommend that manufacturers publish details of the methodologies theyhave used in assessing the safety of their products containing nanoparticles thatdemonstrate how they have taken account that properties of nanoparticles may bedifferent from larger forms.

(iii) We recommend that the ingredients lists of consumer products should identifythe fact that manufactured nanoparticulate material has been added.

(iv) We recommend that the EC’s new Scientific Committee on Emerging andNewly Identified Health risks give a high priority to the consideration of the safety ofnanoparticles in consumer products.

(v) In the light of the regulatory gaps that we identify we recommend that the EC(supported by the UK) review the adequacy of the current regulatory regime withrespect to the introduction of nanoparticles into consumer products. In undertakingthis review they should be informed by the relevant scientific safety advisorycommittees.

R13 We recommend that the Department of Health review its regulations for newmedical devices and medicines to ensure that particle size and chemistry are takeninto account in investigating possible adverse side effects of medicines.

R14 We recommend that manufacturers of products that incorporate nanoparticles andnanotubes and which fall under extended producer responsibility regimes such asend-of-life regulations be required to publish procedures outlining how thesematerials will be managed to minimise human and environmental exposure.





R15 (i) We recommend that researchers and regulators looking to develop methods tomeasure and monitor airborne manufactured nanoparticulates liaise with those whoare working on the measurement of pollutant nanoparticles from sources such asvehicle emissions.

(ii) We recommend that the Department of Trade and Industry supports thestandardisation of measurement at the nanometre scale required by regulators and forquality control in industry through the adequate funding of initiatives under its NationalMeasurement System Programme and that it ensures that the UK is in the forefront ofany international initiatives for the standardisation of measurement.

Appendix IIHSE (2004b) A review of the toxicity of particles that are intentionally produced for usein nanotechnology applications, seen from an occupational health perspective.3

Summary and conclusions

1 There is a paucity of information and extensive gaps in our knowledge of thepotential health effects of particles intentionally produced for nanotechnologyapplications. This lack of information and understanding applies particularly to novelnanoparticles, such as carbon nanotubes. The limited information that is available,certainly for carbon nanotubes, suggests that they do possess significant inherenttoxicity, at least towards the respiratory tract.

2 There is an extensive body of information on the health effects of existingmicrometre-sized particulate material, particularly towards the respiratory tractfollowing inhalation exposure. Some studies have compared this toxicity with thatproduced when the material is rendered nanometre-sized. The general picture thatemerges from experimental animal studies is that on a mass dose basis, pulmonarytoxicity is enhanced when particle size is reduced from the micrometre to thenanometre range. The increase in toxicity appears to be related, at least in part, to theincrease in particle surface area. However, what also becomes apparent from the datais that different existing materials in the nanometre size range exhibit different degreesof toxicity towards the respiratory tract. The reasons for these differences are currentlypoorly understood. Consequently, it is not possible to reach generic conclusionsabout toxicity based on consideration of size alone; the potential toxicity of eachindividual nanoparticulate material needs to be considered on a case by case basis.

3 Consideration of the potential toxicological properties of particulate materialsintentionally produced for use in nanotechnology applications must address theconsequences of exposure in terms of local and systemic effects, following single andrepeated exposure by relevant routes. For the occupational setting, the exposureroutes of relevance are inhalation and dermal.

4 One aspect that may be of particular importance to the novel carbon-basedmaterials, the production of which involves the use of metal catalysts, is the issue oftoxicity due to the residual metal contained within the final product. Such metals mightcontribute to the overall expression of toxicity by the material, either from their locationwithin the material or by leaching out from it. For example, exposure to nickel couldbe an issue for some carbon nanotubes, which have a relatively high (by mass)residual nickel content. Further information on the residual metal content of carbonnanotubes and other nanoparticles and leaching rates in biological systems would berequired to determine whether metal exposure is likely to be important in theexpression of respiratory tract, and any other toxicity.



5 Overall, therefore, there is a clear lack of information on the potential healtheffects of nanoparticles produced for nanotechnology applications. From the limitedinformation that is available, the indications are that they might possess significanttoxicity potential.

Appendix IIIPritchard (2004) Literature review – explosion hazards associated withnanopowders.4

Executive summary

Objectives1 Nanopowders are composed of particles in size range from about 1 to 100nanometres (nm). One nanometre is equivalent to 10-9 metres. The growingdemand for nanopowders arises from the change in physical, chemical andelectrical properties exhibited by particles when their size falls below about 100 nm.The laws of quantum physics, rather than the laws of classical physics, come intoplay at these small particle sizes and the behaviour of the surfaces start todominate the bulk behaviour of the material. For example, materials that wouldnormally be conductors of electricity can become insulators at the nanoscale, orvice versa. Titanium dioxide and zinc oxide, which are widely used in sunscreens,become transparent at the nanoscale, a cosmetically desirable property forsunscreen products. Nanopowders are also referred to as nanomaterials,nanoparticles or ultra fine particles.

2 Along with the increasing production and use of nanoscale particles there hasbeen a growing concern over the impact of this new technology on health andsafety and the environment. This has almost exclusively concentrated on thepotential health hazards of nanopowders. One potential hazard that appears tohave received little attention to date is their explosibility. A literature review has beencommissioned by the Corporate Science and Knowledge Unit (CSKU) of HSE toexplore the use of nanopowders in industry and the potential explosion hazards.This report presents the findings of the review and assessment of the explosionrisks associated with the processing and use of nanopowders.

Main findings3 An increasing range of materials that are capable of producing explosive dustclouds are being produced as nanopowders. At the same time new uses ofnanopowders are further adding to the demand for these powders. While some ofthese nanopowders are only being produced in very small quantities at present,and may continue to be for the foreseeable future, the production of others is likelyto increase significantly over the next few years.

4 There is a growing concern over the impact the increased use of nanopowdersand other nanomaterials will have on health and safety and the environment. Theseconcerns are almost exclusively centred on the potential toxic effects ofnanomaterials. The potential explosion hazards of nanopowders have not beenaddressed.

5 There is a considerable body of knowledge on the explosion characteristics ofmicronscale powders (particle sizes ranging from about 10 to 500 mm). A literaturesearch has found no data for nanopowders (particle sizes of 1 to 100 nm). It isconsidered that the extrapolation of the data for larger particles to the nanosizerange cannot be carried out with any degree of confidence, due to marked changein the chemical and physical properties of particles below sizes of about 100 nm.



Recommendations6 It is recommended that the explosion characteristics of a representative rangeof nanopowders be determined using the standard apparatus and proceduresalready employed for assessing dust explosion hazards. Comparison with data formicronscale powders of the same materials will allow knowledge of particle sizeeffects to be extended into the nanosize range.

7 Although it is recommended using standard apparatus and procedures formeasuring the explosion characteristics of nanopowders, if agglomeration isthought to be occurring in the test vessel it may be necessary to modify the waythe powder is dispersed. This is to ensure that the worst-case characteristics willbe measured.

Appendix IVAitken et al (2004) Nanoparticles: An occupational hygiene review.5

Executive summary

1 Nanotechnology is a broad interdisciplinary area of research, development andindustrial activity which has been growing rapidly worldwide for the past decade. Itis a multidisciplinary grouping of physical, chemical, biological, engineering andelectronic processes, materials, applications and concepts in which the definingcharacteristic is one of size. Nanoparticles are the end products of a wide variety ofphysical, chemical and biological processes some of which are novel and radicallydifferent, others of which are quite commonplace. In this review we have focusedon processes for the deliberate development and manufacture of nanoparticleproducts. Nanoparticle products include nanotubes, nanowires, quantum dots and‘other’ nanoparticles. We have reviewed and considered the following, fornanoparticle production processes:

■ potential routes for human exposure;■ industrial sources of occupational exposure;■ level of exposure;■ means of, and effectiveness of control measures;■ potential numbers exposed;■ ease with which gaps in knowledge could be filled;■ trends in the (potential) use of nanotechnology;■ views as to the likely impact of the transition from research use to full-scale

industrial use.

2 The review is comprised of four main elements:

■ a conventional scientific review;■ a web-based review;■ discussion with key individuals prominent in relation to scientific or industrial

development of nanoparticles, their health effects or risk assessment; and ■ the experience and interpretation of the project team.

Conclusions

3 Based on our review of occupational hygiene aspects of nanoparticleproduction, we conclude that:

■ There are four main groups of nanoparticle production processes (gas-phase,vapour deposition, colloidal and attrition) all of which may potentially result inexposure by inhalation, dermal or ingestion routes.

■ From an occupational hygiene perspective, the processes are not dissimilar toexisting chemical production processes.

■ Only gas-phase processes have the potential to cause exposure to primarynanoparticles by inhalation during the synthesis stage. All processes may giverise to exposure (by inhalation, dermal and ingestion) to agglomeratednanoparticles during recovery, powder handling and product processing.

■ For exposure by inhalation, control approaches and methods are availablewhich should be effective in nanoparticle processes.

■ For dermal or ingestion exposure, control methods based on personalprotective equipment may not be as effective as they are in existing processes.

■ The most appropriate metric in most cases for assessment of inhalationexposure to nanoparticles is particle surface area. There are no effectivemethods currently available that enable particle surface to be assessed in theworkplace.

■ Current knowledge is inadequate for risk assessment purposes.■ No information has been identified about workers’ exposures to nanoparticles

in the university/research sector or in the new nanoparticle particle companiesin the UK.

■ Only very limited information is available for existing chemical, pharmaceuticaland refining companies. Information from other powder handling processesindicates that exposures may be significant.

■ Approximately 2000 people currently employed in the university/researchsectors and new nanoparticle companies are involved in activities in which theymay potentially be exposed to nanoparticles in some form. A maximum of 500workers are considered to be potentially exposed to nanoparticles throughexisting ultra fine manufacturing processes, mostly through the manufacture ofcarbon black. Around 100 000 individuals may potentially be exposed to finepowders through various powder handling processes, including thepharmaceutical industry. It is not possible to say what proportion of these maybe exposed to nanoparticles. More that 1 000 000 workers in the UK may beexposed to nanoparticles via incidental production in processes such aswelding and refining.

■ The number of people in the university/research sector and in new nanoparticlecompanies may double over the next five years. The proportion of thoseinvolved in existing chemical and pharmaceutical companies and in otherpowder handling activities who are exposed to nanoparticles is likely toincrease.

4 In summary, we conclude that there is little evidence to suggest that theexposure of workers arising from the production of nanoparticles has beenadequately assessed.



Knowledge gaps

5 Arising from the review we also identified key knowledge gaps and maderecommendations as to how they may be filled. These are:

The nanoparticle nomenclature is not sufficiently well described or agreed Currently there are no agreed definitions for nanoparticles, nanoparticle aerosols, orfor the various types of nanoparticles which are produced. Definitions proposedneed to define a size interval to take account of the distribution in sizes likely to bepresent, to consider whether the definition should be based on physicaldimensions (eg length, diameter, surface area) or on some behavioural propertysuch as diffusivity and also take account of agglomerated aerosols. Progress onnomenclature issues is usually best achieved based on consensus.

There are no convenient methods by which exposures to nanoparticles in theworkplace can be measured or assessed For inhalation, the most appropriate metric for assessment of exposure to mostnanoparticles is particle surface area. Currently there are no effective methodsavailable by which particle surface area can be assessed in the workplace. There isa need for more research into the development of new and improved methods,combinations and strategies to provide reliable assessments of exposure tonanoparticles and nanoparticle aerosols. Development of appropriate methods toevaluate dermal and ingestion exposure is also necessary. HSE should considerhow best to promote the development of appropriate metrics and exposureassessment approaches.

Insufficient knowledge concerning nanoparticle exposure is availableMuch more information is needed regarding the exposure of workers involved inthe production of all of the various types of nanoparticles via all of the productionprocesses. In the absence of suitable measurement systems, coherent approachesas described above should be adopted. At this stage there is insufficient evidenceto judge whether exposure to the various forms of nanoparticles is occurring atsignificant levels in nanoparticle production processes. HSE should consider howto encourage the collection of such data.

The effectiveness of control approaches has not been evaluatedBetter understanding is required relating to the effectiveness of control ofnanoparticles. This will be better informed given the development of appropriatemethods for assessment of exposure to nanoparticles and a better understandingon the levels of exposure that may be acceptable. This is true for both inhalation,dermal and ingestion risks. HSE should consider how to promote the evaluation ofcontrol approaches.

Knowledge concerning nanoparticle risks is inadequate for risk assessmentsCurrent knowledge is inadequate for risk assessment. Risk assessmentapproaches will have to consider how best to use information which is currentlyavailable, and plan to collect new information. An effective strategy for collecting,storing and disseminating this information is also necessary. Development ofappropriate databases and other information resources to collect and disseminateinformation on studies investigating exposure or toxicological assessment ofnanoparticles will be a key element in this. HSE should consider what it can do tocollate, maintain and disseminate information relevant to nanoparticle risk issues.



References

1) HSE 2004(a) Horizons Scanning Information Note No HSIN1Available online at: www.hse.gov.uk/pubns/hsin1.pdf

2) Nanoscience and nanotechnologies: opportunities and uncertainties The RoyalSociety and The Royal Academy of Engineering London 2004

3) HSE 2004(b) Health effects of particles produced for nanotechnologies HSEHazard assessment document EH75/6 December 2004 Available online at:www.hse.gov.uk/horizons/nanotech/healtheffects.pdf

4) Pritchard D K 2004 Literature review – explosion hazards associated withnanopowders Health and Safety Laboratory Report HSL/2004/12 Available onlineat: www.hse.gov.uk/research/hsl_pdf/2004/hsl04-12.pdf

5) RJ Aitken, KS Creely, CL Tran (2004) Nanoparticles: An occupational hygienereview RR274 HSE Books 2004 ISBN 0 7176 2908 2 Available online at:www.hse.gov.uk/research/rrpdf/rr274.pdf

Further informationHSE produces a wide range of documents. Some are available as printedpublications, both priced and free, and others are only accessible via the HSE website, www.hse.gov.uk.

HSE priced and free publications are available by mail order from HSE Books, PO Box 1999, Sudbury, Suffolk CO10 2WA Tel: 01787 881165 Fax: 01787 313995Website: www.hsebooks.co.uk (HSE priced publications are also available frombookshops and free leaflets can be downloaded from HSE’s website:www.hse.gov.uk.)

For information about health and safety ring HSE’s Infoline Tel: 0845 345 0055 Fax: 0845 408 9566 Textphone: 0845 408 9577 e-mail: [email protected] orwrite to HSE Information Services, Caerphilly Business Park, Caerphilly CF83 3GG.

This document contains notes on good practice which are not compulsorybut which you may find helpful in considering what you need to do.

This document is available web only at www.hse.gov.uk/horizons/nanotech/

© Crown copyright This publication may be freely reproduced, except foradvertising, endorsement or commercial purposes. First published 03/06. Please acknowledge the source as HSE.


Published by the Health and Safety Executive 03/06 22 of 22 pages

Documents

Review of the adequacy of current regulatory regimes to ... · Health and Safety Executive Review of the adequacy of current regulatory regimes to secure effective regulation of nanoparticles